Roche has redoubled its commitment to precision oncology by taking full ownership of Foundation Medicine, a pioneer of genomic tumor profiling, in a deal that values the company at $5.3 billion. It's little more than three years since Basel, Switzerland-based Roche acquired a majority stake in Foundation Medicine, in a transaction that valued the firm at about $1.4 billion at that time. Since then, the company has more than doubled its business and, crucially, obtained both FDA approval and Centers for Medicare & Medicaid Services (CMS) coverage for its diagnostic test FoundationOne CDx (F1CDx), which detects a large number of genomic alterations associated with cancer. However, precision oncology, the notion of matching cancer patients with the best available therapy on the basis of their genomic profile, is still an emerging—and, to some critics, an unproven—approach. The Roche acquisition was “really an affirmation of the utility of precision medicine,” says David Fabrizio, cancer immunotherapy leader at Foundation Medicine. “For the rest of the world, there is still a question of the utility of this.”
The whole promise of precision oncology ultimately resides in identifying a clinically useful treatment suggested by the genomic analysis of a given tumor. In practice, the outcome is often far from a panacea for patients. Many targeted drugs are only moderately effective. Combination therapies, which may be suggested by genomic analysis, may not be feasible to administer for clinical reasons, such as the risk of unknown toxicities, or for logistical reasons, such as a lack of access to an appropriate clinical trial if an investigational drug is recommended. Memorial Sloan Kettering Cancer Center reported that although 37% of patients with advanced cancer whose tumors were analyzed had clinically relevant genetic alterations, only 11% (of the first 5,009 patients analyzed) were enrolled onto a genomically matched trial (Nat. Med. 23, 703–713, 2017). The precision oncology ideal is still only being realized in a minority of cases. “There are many roadblocks to making it happen at scale,” says Arul Chinnaiyan, professor of pathology and urology at the University of Michigan and a Howard Hughes Medical Institute Investigator. “We're not there yet.” An additional challenge is that patients are more likely to undergo genomic analysis at a late stage rather than at an early stage in their disease course. For many, it may be too late to make a useful intervention. “We're essentially trying to apply a precision oncology approach to these highly evolved tumors,” Chinnaiyan says.
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